Insomnia during perimenopause
Conditions
Interventions
Stellate Ganglion Block plus Hormone Therapy Group:Stellate Ganglion Block combined with Sequential Estrogen-Progestogen Therapy
Hormone Therapy Group:Sequential Estrogen-Progestogen Therapy
Sponsors
The Third Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Women with insomnia during perimenopause. Insomnia: According to the diagnostic criteria for chronic insomnia in the Third edition of the International Classification of Sleep Disorders (ICSD-3). Perimenopause: 40-60 years old,Irregular menstruation or amenorrhea that has occurred for at least 3 months but less than 12 months within the past 3 months.
Exclusion criteria
Exclusion criteria: 1.Coagulation disorders; 2.Refusal to consent to stellate ganglion block (SGB) or hormone therapy; 3.Allergy to local anesthetics; 4.Concurrent participation in another clinical trial; 5.Concomitant use of other medications for treating insomnia, e.g., hypnotics, traditional Chinese herbal medicines, etc.; 6.Known or suspected pregnancy; 7.Unexplained vaginal bleeding; 8.Known or suspected breast cancer; 9.Known or suspected hormone-dependent malignant tumors; 10.History of thromboembolic disease within the past six months; 11.Severe hepatic or renal insufficiency; 12.Insomnia attributable to other etiologies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Remission Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum serotonin level;Pittsburgh Sleep Quality Index (PSQI);Patient Health Questionnaire-9 (PHQ-9) Score;Hot flash and sweating severity;Brain fog self-assessment scale scores;corticotropin-releasing hormone (CRH);Kupperman scores;Insomnia Severity Index (ISI) Score;Serum melatonin level;Generalized Anxiety Disorder 7-item scale (GAD-7); | — |
Countries
China
Contacts
Public ContactShaoli Zhou
The Third Affiliated Hospital Sun Yat-sen University
Outcome results
None listed